Target Populations for First-In-Human Embryonic Stem Cell Research in Spinal Cord Injury

Abstract

Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, subacute incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial.

I Miss Being Me: Phenomenological Effects of Deep Brain Stimulation

“…This evidence justifies the claim that, generally speaking, DBS is not a threat to personal, but some patients might not experience well any form of estrangement. Patients would benefit from being informed ahead of any potential risks, prior to consenting to being implanted, as in other types of invasive brain intervention (Viaña, Vickers et al 2017;Gilbert et al 2014;Viaña, Bittlinger et al 2017;Gilbert 2015b;Bretzner et al 2011;Gilbert, Vranic, and Hurst 2013;Gilbert 2014;Vranic & Gilbert 2014;Gilbert & Cook 2015;Gilbert 2017;Gilbert & Dodds 2013;Gilbert & Focquaert 2015;Gilbert & Vranic 2015).…”

Models of CNS injury in the nonhuman primate: A new era for treatment strategies

“…Grafting of engineered human neural stem cells onto the rat forebrain following hypoxic-ischemic injury promoted axonal sprouting and improved recovery [197,198]. Stem cell transplantation therapies have also been proposed for the treatment of retinal diseases [199], ischemic injuries [200] and TBI [201,202] announced by Geron [205,206], but has since been discontinued, citing funding and financial reasons [207]. Implantation of the NT2/D1 precursor cell line (human embryonic carcinoma-derived) has also been previously trialed in human stroke patients.…”

Global Update: USA

“…The trial is a treatment for acute spinal cord damage for individuals with complete thoracic-level injuries. While no results have been released, the trial itself has already caused debate among researchers and ethicists [6][7][8].…”